Partner Notification Following STI Diagnosis Clinical Trial
Official title:
Partner Notification Strategies for STI Control in Urban Peru
The goal of the proposed research is to assess new strategies for partner management and sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the core risk group of MSM. STI infection and re-infection are central to the continuation of the HIV epidemic among MSM in Peru. Development of improved strategies for partner notification and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the incidence of HIV infection in this population. The first phase of this study used qualitative methods to explore attitudes and practices related to partner notification among MSM in Lima, Peru. Findings from the qualitative research were used to develop a quantitative survey instrument to assess partner notification decision-making processes and practices among MSM in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and qualitative phases of the study have been used to develop a partner notification for MSM in Peru. Investigators plan to implement and assess the impact of the intervention on rates of partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The investigators hypothesize that participants randomized to receive one or more partner notification tools will report a higher frequency of partner notification.
Specific Aim: To assess the efficacy of internet- and referral card-based partner
notification tools for the improvement of partner notification outcomes among MSM in Lima,
Peru. As attitudes and behaviors related to partner notification vary within specific
behavioral, social, and clinical contexts, interventions designed to improve partner
notification outcomes must address the same contextual determinants to be effective. Partner
notification tools based on electronic distribution of anonymous notification messages
and/or patient-delivered referral cards are expected to increase notification rates in
specific contexts.
Hypothesis: Provision of partner notification tools based on electronic and printed
resources will improve reported and observed partner notification outcomes by overcoming
barriers to notification including limited contact information, fear of disclosure, stigma,
and lack of informational resources. Notification outcomes and use of notification tools
will vary according to strategies of interpersonal communication reflected in the specific
behavioral, social, and biomedical contexts of the individual, the partnership, and the STI
diagnosed.
Participants will be selected for participation in the study depending on the findings of
the EPT/Partner Notification Screening Protocol. Participants in the EPT/Partner
Notification Screening Protocol diagnosed with new syphilis infection will be eligible for
enrollment in the Partner Notification protocol.
I. Recruitment: Participants in the EPT/Partner Notification Screening Protocol who are
diagnosed with syphilis based on physician interpretation of results of RPR assay and
clinical history will be invited by the Study Counselor to participate in the Partner
Notification Intervention Protocol.
II. Informed Consent: All potential subjects will receive an explanation of the study
procedures and risks and benefits and asked to provide written Informed Consent.
Participants will be given the opportunity to take the Informed Consent Document home for
further review and decide at a later time if they wish to participate in the study.
III. Enrollment: Subjects who consent to participate in the Partner Notification
Intervention Protocol will be randomized to either the experimental Partner Notification
intervention or the Standard of Care (Partner Notification Counseling) arm.
IV Randomization: Eligible subjects who provide consent to participate will be randomly
assigned to intervention or control groups using a random permuted block allocation (block
size=7 in an alternating 4/3 ratio). Computer-generated randomization assignments will be
stored in opaque, sealed envelopes opened at the time of allocation. Randomization
assignments will be recorded and identified by the participant's numeric study code.
V. Intervention Delivery. Participants assigned to the experimental Partner Notification
intervention will be provided with standard partner notification counseling as well as 5
printed referral cards with information about syphilis infection and a referral sheet for
the Spanish language version of the inSPOT internet-based partner notification service
(www.inspot.org). Referral cards will include printed material informing the recipient that
they may have been exposed to syphilis, and will provide information on syphilis infection,
including local resources for testing and treatment. The inSPOT website is a free
internet-based notification service that offers anonymous automated e-mail partner
notification services following an STI diagnosis. Users of the system select a diagnosis as
well as a standardized notification message which they can personalized with their name and
other messages if they desire. The user then enters the e-mail address(es) of the person(s)
they wish to notify and the system delivers an automated e-mail notification to the person
advising them of their potential exposure to an STI and advising them to seek STI testing.
The notification also includes the address of the inSPOT website which contains additional
information on HIV/STIs, risks for transmission, and resources for testing and treatment.
Participants will be instructed on how to use both tools to assist them in the partner
notification process.
Participants randomized to the control arm will receive standard partner notification
counseling by study staff, without any supplemental notification tools.
Following delivery of the intervention, an appointment will be scheduled for participants to
return to the research site in 1 month.
VI. Follow-up Evaluation. All participants will be asked to return to the study site 1 month
after enrollment and randomization. At the Follow-up evaluation, participants will complete
a brief survey (Partner Notification Follow-up Survey).
VII. Survey: Participants will complete a brief follow-up survey assessing their general
partner notification behavior as well as the actual notification and treatment outcome for
each of their three most recent partners, as well as factors that impeded and/or promoted
partner notification and treatment. Participants will be asked to specify whether each
partner was notified, whether they received antibiotic treatment and/or sought STI testing,
the participant's degree of certainty of the outcomes, and the reasons why each partner was
or was not notified and/or treated.
VIII. Confirmation of Partner Notification: In order to provide independent confirmation of
participant-reported notification status, study staff will ask participants for permission
to conduct third party partner notification and confirmation of reported notification
status. Participants will be asked for permission to contact their recent partner(s) by
telephone or e-mail to confirm the notification outcome. Subjects will be informed that they
are not obligated to provide contact information for any of their partners. Subjects will
also be informed that if they provide contact information for their partner(s), study staff
will contact the person using the contact information provided and notify the person only
that someone they recently had sex with has been diagnosed with syphilis, provide
information on local sites offering free or low cost testing for HIV and STIs, and answer
any questions the partner might have. Subjects will be informed that study staff will not
reveal the participant's name or other identifying information to their partner(s). If the
participant provides contact information for their partner(s), study staff will contact the
person and provide third-party partner notification using an IRB-approved script. After
completing the partner notification process, study staff will ask the partner only if they
had previously been notified by a partner about an STI diagnosis ("Yes/No"). Partners will
not be asked for any additional information.
IX. Qualitative Evaluation. A randomly selected subgroup of participants in the Partner
Notification Intervention Protocol will be invited to participate in individual interviews
about the partner notification process. Each participant will be asked to participate in two
interviews, one following randomization and one following the Follow-up Visit. Participants
will complete a separate informed consent process for the individual interview and will
receive additional compensation for their participation.
X. Eligibility. A randomly selected subset of participants from the Partner Notification
intervention protocol will be invited to participate in the individual qualitative
interviews. Every fourth participant randomized will be invited to participate in an
individual interview until reaching the projected qualitative study sample of 20
participants (10 each from the intervention and control arms). Participants will be asked to
complete a separate informed consent document indicating their willingness to participate in
a qualitative interview.
XI. Interview Conduct. Interviews will be conducted in Spanish in a private room by a
trained interviewer. Interviews will be recorded and transcribed verbatim. Participants will
be advised that they can stop the interview at any time and that they will be able to stop
the tape and erase any response during the interview if they desire.
XII. Interview Content: Baseline interviews will focus on individual decision-making
processes regarding partner notification in specific partnership contexts with a focus on
the influence of: STI-related stigma and shame; the gender and sexual identity of
participants and their partner(s); perceived power differentials within the partnership(s);
patterns of communication within the partnership(s); and structural access to testing and
treatment.
Follow-up interviews will discuss actual notification and treatment outcomes. Follow-up
interviews will emphasize: barriers or catalysts to implementing notification decisions in
specific partnership contexts; structural access to partner testing and treatment within
local social, cultural, and economic contexts; and the effectiveness of the study's
quantitative outcomes in accurately measuring participants' lived experiences.
Each interview is expected to last approximately 20-30 minutes. Audio recordings and
transcripts of interviews will be identified by the participant's numeric study code and the
date of the interview.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention